Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word “complications” means on a device’s warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.
The film, which premieres Friday, July 27, on Netflix, traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that’s inserted into the Fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led to her nearly bleeding to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did. Neither woman’s story takes a turn for the better, but it’s the Latina woman whose entire life — and the lives of her daughters — gets smashed all because of one doctor not taking her concerns seriously.
Dick seems to anticipate that viewers — just like doctors — may be conditioned to think women exaggerate their pain, so at the 15-minute mark of the film he jumps into the story of a respected older white male doctor who got a cobalt hip joint and began suffering from neurological issues. These were so severe that he had a complete mental breakdown in a hotel room, smashing things and scrawling cryptic messages on the walls. He begins questioning established medicine’s embrace of cobalt implants; upon the removal of his, every neurological issue he had developed disappeared. If a completely healthy man with medical training can go so quickly from zero to delusional, what of the millions of other Americans with cobalt in their bodies? What of the injured vets already fighting PTSD who live with an implant that could be poisoning them? What are the metal plates and screws in my own ankle made of, and why didn’t I know to ask?
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The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which — even according to a former head of the department — is a broken system. The medical device industry is the least understood and regulated under the FDA umbrella. Dick exposes so much that I yelled “Oh my God!” multiple times while watching. There is nothing more upsetting than listening to a charming Southern woman say the words, “My colon’s falling out!” Worse yet are the profit-hungry companies that have been able to slide by unnoticed for so long. Here’s hoping The Bleeding Edge gets the right attention on a decidedly unsexy topic.